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Affiliate: Roche Diagnostics Korea
Division : Disease Management Solutions
Work location: Seoul, South Korea
Your key responsibilities
Roche Sponsored Studies(RSS) Protocol Development Support and Budgeting
Coordinating Investigator Initiated Study(IIS) for internal review and tracking IIS status
Ensuring the product meets all government regulations and standards
Assists in all aspects of study design, implementation, and administration, ensuring compliance with IRB.MFDS requirements, regulations, and grant and/or contract
Perform activities in the preparation, initiation, monitoring and closure for an agreed number of sites in all Roche Sponsored Studies(RSS) according to RDK Procedural Documents, international guidelines such as ICH and GCP as well as relevant local regulations
SOP Development and Revision
To ensure quality and quantity commitments are achieved in a timely manner.
Communication with internal employee to find unmet needs of internal customers and involve in evidence generation strategy for product launch, premium price and product claims.
Training, supervising and supporting to CRA
Who you are
Education & Qualification
Bachelor degree above, in pharmacy, nurse, science or related discipline preferred
Experience
+3~10 years of relevant working experience preferred in healthcare industry (The position title will be determined in accordance with the company's standards)
Clinical research related experience preferred
Proven Project/product management experience
Provide clinical input and support for planning post-market launch
Competencies
Makes strategic decisions in partnership with stakeholders
Medical writing and speaking
Understanding on scientific and medical publication
Strong knowledge in KGCP, ICH-GCP
Skills in documentation and archiving
Ability to priorities, plan& evaluate deliverables
Good command of spoken and written English
Good oral and written communication skills
Computer literacy desirable
Teamwork and Collaboration
Submission
English and Korean resume and self-introduction in 1 MS Word file or PDF file.
Please include your current salary and expected salary information in resume.
국, 영문 이력서와 국, 영문 자기소개서를 1개의 MS Word 혹은 PDF 파일로 제출
이력서 상단에 현재 연봉과 희망 연봉을 반드시 표기하시기 바랍니다. 누락 시 이력서가 검토되지 않습니다.
(보훈)취업지원대상자 우대-취업지원대상자증명서 반드시 제출 요망
Next Step
1. Job application screening 서류 전형
2. Interview 면접 전형
- Interview will be informed to the candidate who passes the resume screen test.
- 면접은 서류전형 합격자에 한해 개별 통보합니다.
- 실무진 면접, 임원 면접
- 면접 일정은 해외지사에서 담당하고 있으며, 일정 확인을 위해 해외 번호(중국)로 연락이 갈 수 있는 점 미리 안내드립니다.
3. Overall assessment 종합 심사
4. Final notification via job offer letter 최종 합격 통지
* The finalist is selected after the comprehensive assessment which includes candidates’ reference check, background check on employment history, education, etc and medical check-up.
채용이 유력한 후보자에 대해서 이력 검증 및 평판 조회, 건강검진 등의 종합심사를 진행하여 최종 합격자를 선정합니다.
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.